The purpose of this study is to assess the feasibility of conducting an Internet-based prospective pregnancy study with preconception enrollment with women completing daily journals for up to 12 months while trying to conceive and weekly through pregnancy if it occurs.

Women ages 18-44 without a history of fertility problems who are in a stable relationship with a male partner who have regular access to the Internet and have been trying to conceive <3 months.

Detailed Description:

There is a dearth of knowledge regarding the role that preconception health plays in fertility and early pregnancy loss. Classical methods of conducting prospective pregnancy studies with preconception enrollment to answer these questions are time-consuming in terms of recruitment efforts and expensive to carry out. The purpose of this project is to assess the feasibility of conducting an Internet-based prospective pregnancy study with preconception enrollment in the United States using the gold standard data collection approach of daily diaries during the trying to conceive period. We will accomplish this by enrolling 200 females of reproductive age who attempting to conceive and following them for up to 12 months and through pregnancy for those who become pregnant. Feasibility will be assessed by measuring: the number of women who screen eligible, the number of women who enroll, and compliance with journal use over time. We will also estimate the incidence of infertility, pregnancy and pregnancy loss as well as compare the demographics of women who enroll to the demographics of women who participate in community-based prospective pregnancy studies with preconception enrollment. The data from this project will be used to assess the feasibility of launching a larger prospective pregnancy study that is appropriately powered to examine the impact of preconceptional lifestyle factors on the incidence of infertility and early pregnancy loss.

Eligibility

Ages Eligible for Study:

18 Years to 44 Years (Adult)

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Sampling Method:

Non-Probability Sample

Study Population

We are looking for women ages 18-44 who are planning a pregnancy and have been trying to conceive for <3 months. Women must have reliable daily access to the Internet. The woman and her male partner may not have any known fertility problems.

Criteria

Inclusion Criteria:

Women

Ages 18-44

In a stable relationship

Sexually active with a male partner

Reliable daily access to the Internet

Exclusion Criteria:

Woman or her partner has a known fertility problem

Trying to conceive for three or more months.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01904669

Locations

United States, Ohio

The Ohio State University College of Medicine

Columbus, Ohio, United States, 43210

Sponsors and Collaborators

Courtney D.Lynch, PhD MPH

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)